Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1771-2018·Announced 2018-05-16

Bard Peripheral Vascular Recalls POWERPORT ClearVUE Implantable Ports

Bard Peripheral Vascular Inc is recalling 181 POWERPORT ClearVUE Slim catheters because the included Patient ID Card has incorrect flushing instructions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. The hazard involves incorrect instructions on packaging rather than a direct defect in the device itself, which aligns with moderate severity criteria for labeling or instruction errors.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has announced a Class II recall of the POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes (REF 5678301). The product is manufactured by Bard Peripheral Vascular Inc.

The recall was initiated because the Patient ID Card packaged with the implantable port contains incorrect instructions for flushing the device. This issue affects 181 units distributed nationwide.

Affected lot numbers include REAN0061, REAP0772, REAT1524, REAV1479, REAV1938, REAW0937, REAW1186, REAW1666, REAY0528, REAY0795, REAZ1529, REBN0024, REBN1581, REBQ0210, REBS1277, REBR1125, REBS1395, REBS2412, REBT1785, REBT2349, REBU0563, REBV0760, and REBW1037. Each lot is identified by its Unique Device Identifier (UDI) code.

Consumers who possess this specific implantable port should check their Patient ID Card for the incorrect flushing instructions and contact their healthcare provider or Bard Peripheral Vascular Inc for further guidance.

The recalled product

Product: POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Manufacturer: Bard Peripheral Vascular Inc
Category: Medical Device — Implantable Port / Catheter
Hazard: mis-labeling
incorrect-instructions
Affected units: 181

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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